CA3122902A1 - Formulations d'anticorps - Google Patents

Formulations d'anticorps Download PDF

Info

Publication number
CA3122902A1
CA3122902A1 CA3122902A CA3122902A CA3122902A1 CA 3122902 A1 CA3122902 A1 CA 3122902A1 CA 3122902 A CA3122902 A CA 3122902A CA 3122902 A CA3122902 A CA 3122902A CA 3122902 A1 CA3122902 A1 CA 3122902A1
Authority
CA
Canada
Prior art keywords
antibody
seq
pharmaceutical formulation
present disclosure
disclosure provides
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3122902A
Other languages
English (en)
Inventor
Bodo Brocks
Robert KELLERER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Morphosys AG
Original Assignee
Morphosys AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Morphosys AG filed Critical Morphosys AG
Publication of CA3122902A1 publication Critical patent/CA3122902A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La présente invention concerne des formulations d'une protéine de liaison à un antigène pharmaceutiquement active, telle qu'un anticorps monoclonal. En particulier, la présente invention concerne une formulation pharmaceutique lyophilisée stable d'un anticorps anti-CD38, une formulation liquide reconstituée d'une telle formulation lyophilisée, et des procédés de fabrication et d'utilisation de telles formulations lyophilisées et reconstituées.
CA3122902A 2018-12-14 2019-12-13 Formulations d'anticorps Pending CA3122902A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18212591 2018-12-14
EP18212591.4 2018-12-14
PCT/EP2019/085049 WO2020120730A1 (fr) 2018-12-14 2019-12-13 Formulations d'anticorps

Publications (1)

Publication Number Publication Date
CA3122902A1 true CA3122902A1 (fr) 2020-06-18

Family

ID=64665564

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3122902A Pending CA3122902A1 (fr) 2018-12-14 2019-12-13 Formulations d'anticorps

Country Status (14)

Country Link
US (2) US20220110872A1 (fr)
EP (1) EP3893841A1 (fr)
JP (2) JP7608334B2 (fr)
KR (1) KR20210104736A (fr)
CN (1) CN113194925B (fr)
AU (2) AU2019395841B2 (fr)
BR (1) BR112021011399A2 (fr)
CA (1) CA3122902A1 (fr)
IL (2) IL283886B2 (fr)
MX (1) MX2021007047A (fr)
NZ (1) NZ775172A (fr)
SG (1) SG11202104012QA (fr)
TW (1) TWI820270B (fr)
WO (1) WO2020120730A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
CN116643056B (zh) * 2022-02-15 2025-02-18 厦门万泰凯瑞生物技术有限公司 促甲状腺激素受体复合物、试剂盒、制备方法和用途
IL321745A (en) * 2022-12-27 2025-08-01 Shanghai Henlius Biotech Inc Pharmaceutical preparation containing anti-tigit antibody
AU2024315861A1 (en) * 2023-08-02 2026-02-19 Regeneron Pharmaceuticals, Inc. Cancer therapies targeting vista as monotherapy or in combination with anti-pd1 antibody to treat cancer
TW202545561A (zh) * 2024-01-16 2025-12-01 德商莫菲西斯有限責任公司 抗體的高度濃縮液體製劑

Family Cites Families (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
CA2293632C (fr) 1997-06-12 2011-11-29 Research Corporation Technologies, Inc. Polypeptides d'anticorps artificiels
CA2329940A1 (fr) 1998-06-05 1999-12-09 Mayo Foundation For Medical Education And Research Traitement du myelome multiple au moyen d'anticorps du cd38 obtenus par genie genetique
EP1174440A1 (fr) 2000-07-19 2002-01-23 U-BISys B.V. Un épitope exprimé sélectivement sur la molécule humaine CD38 et détecté par un fragment d'un anticorps humain de forme scFv dérivé d'une librairie "phage display"
US20030113316A1 (en) * 2001-07-25 2003-06-19 Kaisheva Elizabet A. Stable lyophilized pharmaceutical formulation of IgG antibodies
EP1720907B1 (fr) 2004-02-06 2015-04-08 MorphoSys AG Anticorps humains anti-cd38 et utilisations de ceux-ci
WO2006125640A2 (fr) 2005-05-24 2006-11-30 Morphosys Ag Production et profilage d'anticorps therapeutiques entierement humains hucal gold®; propres a la molecule cd38 humaine
JO3000B1 (ar) * 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
IL296666A (en) 2005-03-23 2022-11-01 Genmab As Antibodies against 38cd for the treatment of multiple myeloma
CN103554260A (zh) 2005-10-12 2014-02-05 莫佛塞斯公司 特异性针对人CD38的完全人HuCAL GOLD-衍生治疗抗体的生成和鉴定
EP1914242A1 (fr) 2006-10-19 2008-04-23 Sanofi-Aventis Nouveau anticorps Anti-CD38 pour le traitement du cancer
EP2025722A1 (fr) * 2007-07-30 2009-02-18 Nanoresins AG Procédé destiné à la fabrication d'un nanodioxyde de silicium
WO2010088444A1 (fr) * 2009-01-29 2010-08-05 Medimmune, Llc Anticorps humains anti-il-6 à demi-vie prolongée in vivo et leur utilisation en oncologie et pour le traitement de maladies autoimmunes et inflammatoires
PL2580243T3 (pl) 2010-06-09 2020-05-18 Genmab A/S Przeciwciała przeciwko ludzkiemu CD38
JOP20210044A1 (ar) 2010-12-30 2017-06-16 Takeda Pharmaceuticals Co الأجسام المضادة لـ cd38
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
SG11201401518TA (en) 2011-10-28 2014-05-29 Teva Pharmaceuticals Australia Pty Ltd Polypeptide constructs and uses thereof
US20140004131A1 (en) * 2012-05-04 2014-01-02 Novartis Ag Antibody formulation
CA2885792C (fr) * 2012-09-25 2021-09-28 Jan Endell Combinaison pharmaceutique d'un anticorps anti-cd38 et de melphalan pourle traitement du myelome multiple
DK2914302T3 (en) * 2012-11-05 2017-04-10 Morphosys Ag RADIOACTIVALLY MARKED ANTIBODY AND USES OF IT
US11576863B2 (en) * 2013-03-15 2023-02-14 Takeda Pharmaceutical Company Limited Formulation of an antibody and use thereof
FI3677591T3 (fi) 2013-04-29 2023-04-03 Teva Pharmaceuticals Australia Pty Ltd Anti-cd38-vasta-aineet ja fuusiot heikennetylle interferonille alfa-2b
EP3063173B1 (fr) 2013-10-31 2020-07-29 Sanofi Anticorps anti-cd38 spécifiques pour le traitement de cancers humains
US9732154B2 (en) * 2014-02-28 2017-08-15 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia
AU2015237184B2 (en) 2014-03-28 2020-11-26 Xencor, Inc. Bispecific antibodies that bind to CD38 and CD3
MA41019A (fr) 2014-11-26 2021-05-05 Xencor Inc Anticorps hétérodimériques se liant aux antigènes cd3 et cd38
DK3294769T3 (da) * 2015-05-13 2021-03-08 Morphosys Ag Behandling for multipelt myelom (mm)
US20170121417A1 (en) * 2015-11-03 2017-05-04 Janssen Biotech, Inc. Subcutaneous Formulations of Anti-CD38 Antibodies and Their Uses
MA43187B1 (fr) 2015-11-03 2021-02-26 Janssen Biotech Inc Formulations sous-cutanée d'anticorps anti-cd38 et leurs utilisations
US10865249B2 (en) 2015-11-10 2020-12-15 University Medical Center Hamburg-Eppendorf Antigen-binding polypeptides directed against CD38
US11603407B2 (en) * 2017-04-06 2023-03-14 Regeneron Pharmaceuticals, Inc. Stable antibody formulation
US20200354453A1 (en) * 2017-05-02 2020-11-12 Merck Sharp & Dohme Corp. Stable formulations of anti-tigit antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof

Also Published As

Publication number Publication date
IL283886B1 (en) 2025-01-01
TWI820270B (zh) 2023-11-01
WO2020120730A1 (fr) 2020-06-18
AU2019395841B2 (en) 2025-02-27
IL283886A (en) 2021-07-29
US20250241859A1 (en) 2025-07-31
NZ775172A (en) 2025-10-31
CN113194925A (zh) 2021-07-30
EP3893841A1 (fr) 2021-10-20
IL283886B2 (en) 2025-05-01
SG11202104012QA (en) 2021-05-28
MX2021007047A (es) 2021-10-26
AU2019395841A1 (en) 2021-05-20
KR20210104736A (ko) 2021-08-25
AU2025203885A1 (en) 2025-06-19
JP2025041732A (ja) 2025-03-26
IL317328A (en) 2025-01-01
TW202034901A (zh) 2020-10-01
US20220110872A1 (en) 2022-04-14
CN113194925B (zh) 2025-03-07
BR112021011399A2 (pt) 2021-09-14
JP2022512294A (ja) 2022-02-03
JP7608334B2 (ja) 2025-01-06

Similar Documents

Publication Publication Date Title
US20250241859A1 (en) Antibody formulations
JP7382232B2 (ja) 抗ｌａｇ３抗体の製剤および抗ｌａｇ３抗体と抗ｐｄ－１抗体との共製剤
CA2634131C (fr) Formulations de proteines a viscosite reduite et leurs utilisations
US9610301B2 (en) Powdered protein compositions and methods of making same
EP3043776B1 (fr) Formulations de protéines liquides contenant des colorants organiques solubles dans l'eau
AU2015257798C1 (en) Liquid formulation comprising GM-CSF neutralizing compound
JP2023071755A (ja) 安定化された抗体溶液
JP6346189B2 (ja) Ｇｍ−ｃｓｆ中和化合物を含む液体製剤
HK40057289A (en) Antibody formulations
HK40057289B (zh) 抗体制剂
WO2025188845A1 (fr) FORMULATIONS STABLES POUR ANTICORPS TNFα ET LEURS UTILISATIONS
TW202606754A (zh) 穩定抗體配製物
TW202541841A (zh) 用於治療ｃ１ｓ介導病症的包含抗體的醫藥組成物及其使用方法
HK40018131A (en) Liquid protein formulations containing ionic liquids

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220920

EEER Examination request

Effective date: 20220920

EEER Examination request

Effective date: 20220920

EEER Examination request

Effective date: 20220920

EEER Examination request

Effective date: 20220920

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 5TH ANNIV.) - STANDARD

Year of fee payment: 5

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20241206

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT DETERMINED COMPLIANT

Effective date: 20241206

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20241206

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 6TH ANNIV.) - STANDARD

Year of fee payment: 6

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20251121

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20251121